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Experimental Tobacco Marketplace in Regulating Flavored Tobacco Products in Menthol Cigarette Smokers

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ClinicalTrials.gov Identifier: NCT03897530
Recruitment Status : Recruiting
First Posted : April 1, 2019
Last Update Posted : October 9, 2019
Sponsor:
Collaborator:
National Cancer Institute (NCI)
Information provided by (Responsible Party):
Roswell Park Cancer Institute

Brief Summary:
This trial uses an Experimental Tobacco Marketplace to study the purchase of tobacco products in menthol cigarette smokers. Determining the level of substitutability of both flavored and unflavored/tobacco flavored e-cigarettes when menthol cigarettes are available and unavailable can help determine if a flavor ban (of either menthol cigarettes and/or flavored e-cigarettes) will lead to smoking cessation and/or harm reduction. A greater understanding of tobacco product purchasing could help inform possible regulatory actions by the Food and Drug Administration.

Condition or disease Intervention/treatment Phase
Cigarette Smoking Behavioral: Smoking Cessation Intervention Other: Functional Assessment Other: Questionnaire Administration Not Applicable

Detailed Description:
Participants view and purchase hypothetical tobacco products during four distinctly different Experimental Tobacco Marketplace (ETM) conditions. During the session, participants are presented with these randomly ordered conditions: menthol cigarettes and five flavored e-cigarettes (menthol/mint, fruits, sweets, alcohol, snacks/meals), menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes, non-menthol cigarettes and five flavored e-cigarettes, and non-menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes. Participants' visual attention is evaluated by eye-tracking equipment.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 206 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Flavored Tobacco Product Regulation: Behavioral Economic Demand, Visual Attention, and Flavored Tobacco Product Availability
Actual Study Start Date : October 1, 2018
Estimated Primary Completion Date : September 24, 2020
Estimated Study Completion Date : September 24, 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Menthol

Arm Intervention/treatment
Experimental: Prevention
During the session, participants are presented with randomly ordered conditions: menthol cigarettes and five flavored e-cigarettes (menthol/mint, fruits, sweets, alcohol, snacks/meals), menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes, non-menthol cigarettes and five flavored e-cigarettes, and non-menthol cigarettes and both unflavored and tobacco-flavored e-cigarettes. Participants' visual attention is evaluated by eye-tracking equipment.
Behavioral: Smoking Cessation Intervention
View and purchase hypothetical tobacco products during four distinctly different ETM

Other: Functional Assessment
Visual attention is evaluated via eye-tracking equipment

Other: Questionnaire Administration
Ancillary studies




Primary Outcome Measures :
  1. Cessation of Menthol flavored cigarettes [ Time Frame: At the time of the session , assessed up to 15 months ]
    Number of flavored cigarettes purchased inThe Experimental Market Place (ETM) will be used to track tobacco purchase behaviors

  2. Eye tracking metrics [ Time Frame: At the time of the session , assessed up to 15 months ]
    the interaction of type of cigarette available (menthol versus non-menthol) and type of e-cigarette available (flavors versus unflavored and tobacco), will employ a 2 X 2 repeated measures ANOVA with post-hoc Bonferroni tests to evaluate the outcomes of Q0 (derived initial consumption without cost constraints), α (demand elasticity), the substitution levels, and the eye-tracking metrics.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Menthol cigarette smokers who report smoking a brand that has a non-menthol equivalent.
  • Residing in Western New York.
  • Voluntarily provide informed consent to participate in the study.

Exclusion Criteria:

  • Any known history of macular degeneration, glaucoma, cataracts, eye implant, permanently dilated pupils or the use of a screen reader/magnifier.
  • The following special populations will not be included:

    • Adults unable to consent
    • Individuals who are not yet adults (infants, children, teenagers)
    • Prisoners
    • Pregnant women

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03897530


Contacts
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Contact: Amanda Quisenberry 1-800-767-9355 Askroswell@roswellpark.org

Locations
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United States, New York
Roswell Park Cancer Institute Recruiting
Buffalo, New York, United States, 14263
Sponsors and Collaborators
Roswell Park Cancer Institute
National Cancer Institute (NCI)
Investigators
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Principal Investigator: Amanda Quisenberry Roswell Park Cancer Institute

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Responsible Party: Roswell Park Cancer Institute
ClinicalTrials.gov Identifier: NCT03897530     History of Changes
Other Study ID Numbers: I 75418
First Posted: April 1, 2019    Key Record Dates
Last Update Posted: October 9, 2019
Last Verified: October 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Menthol
Antipruritics
Dermatologic Agents